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临床试验/NCT02473614
NCT02473614已完成不适用

To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Box and Blocks Test

研究概览

简要总结

Investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to patients with spinal cord injuries. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with minimum of 3 hours of exercise time per week. Participants will receive the other intervention at their 3 week post-therapy follow-up visits. Clinical evaluations will be performed at baseline 1 and 2 (3 to 10 days apart), post-therapy after the first intervention, 3-week post-therapy follow up, post-therapy after the second intervention, and 3-week post-second intervention follow up visits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of spinal cord injury affecting the arm and hand functions, at least 6 months prior to enrollment
  • Upper extremity weakness as measured on a standard clinical scale
  • No active major psychiatric problems, or neurological/orthopedic problems affecting the training upper extremity
  • No active major neurological disease other than the spinal cord injury
  • Absence of pain in the affected upper extremity

排除标准

  • Severe tone at the affected upper extremity as measured on a standard clinical scale
  • Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
  • Difficulty in understanding or complying with instructions given by the experimenter
  • Inability to perform the experimental task that will be studied
  • Increased pain with movement of the training upper extremity

结局指标

主要结局

Box and Blocks Test

时间窗: Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.

We compared the change of Box and Blocks Test (BBT) scores from baseline evaluation to the end of 3-week of therapy, and from 1-month post first intervention to the end of the second 3-week therapy. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate better outcomes.

次要结局

  • Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)(Baseline, EOT 1st Intervention, 1 month post 1 intervention, EOT 2nd Intervention, and 1 month post 2nd Intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelli Sharp

Assistant Professor at the Department of Dance

University of California, Irvine

研究点 (2)

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